CA2272437A1 - Method for producing a therapeutic system in the form of plaster - Google Patents
Method for producing a therapeutic system in the form of plaster Download PDFInfo
- Publication number
- CA2272437A1 CA2272437A1 CA002272437A CA2272437A CA2272437A1 CA 2272437 A1 CA2272437 A1 CA 2272437A1 CA 002272437 A CA002272437 A CA 002272437A CA 2272437 A CA2272437 A CA 2272437A CA 2272437 A1 CA2272437 A1 CA 2272437A1
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- Prior art keywords
- plaster
- active ingredient
- layer
- production
- active
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
- B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
- B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Dermatology (AREA)
- Composite Materials (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to the production, conveyance and storage of a therapeutic system in the form of plaster comprising an active layer which is oversaturated with an active substance. Said layer contains the active substance in a homogenous dispersion or solution. The method is characterized in that when it is carried out it avoids procedural parameters which favour or trigger crystallization of the active substance and avoids all type of pressure effects on the plaster and especially the active layer during implementation.
Description
r Process for the production of a therapeutic system in the form of a plaster D E S C R I P T I O N
The invention relates to a proce~os for the production, transport and storage of a transclermal therapeutic system (TTS) which is in the form of a plaster and has an active layer supersaturated with active ingredient and containing the active ingredient in homogeneous dispersion or in solution.
Transdermal therapeutic systems normally consist of a backing layer which is impermeab7Le to active and inactive ingredients, of an active ingredient-containing and frequently adhesive reservoir layer and of a protecting layer which is to be removed before application and a.s likewise impermeable to active ingredient. In order to achieve release of active ingredLent sufficient for therapeutic purposes, it may be necessary for the active ingredient-containing layer to be supersaturated with active ingredient. Although such supersaturated transdermal therapeutic systems can have a high thermodynamic activity for therapeutic purposes, on the other hand there is the latent risk that the active ingredients will crystallize completely or partly. It is known that the crystallization o:E active ingredient is extremely disadvantageous for it;s release, considerably reducing or completely preventing the latter. It is also known that crystallization of the active ingredient is favoured and/or induced by the operation of pressure on an active ingredient-containing layer.
The invention relates to a proce~os for the production, transport and storage of a transclermal therapeutic system (TTS) which is in the form of a plaster and has an active layer supersaturated with active ingredient and containing the active ingredient in homogeneous dispersion or in solution.
Transdermal therapeutic systems normally consist of a backing layer which is impermeab7Le to active and inactive ingredients, of an active ingredient-containing and frequently adhesive reservoir layer and of a protecting layer which is to be removed before application and a.s likewise impermeable to active ingredient. In order to achieve release of active ingredLent sufficient for therapeutic purposes, it may be necessary for the active ingredient-containing layer to be supersaturated with active ingredient. Although such supersaturated transdermal therapeutic systems can have a high thermodynamic activity for therapeutic purposes, on the other hand there is the latent risk that the active ingredients will crystallize completely or partly. It is known that the crystallization o:E active ingredient is extremely disadvantageous for it;s release, considerably reducing or completely preventing the latter. It is also known that crystallization of the active ingredient is favoured and/or induced by the operation of pressure on an active ingredient-containing layer.
Transdermal therapeutic systems i.n the form of plasters are mostly produced by coating the detachable protecting layer with an active ingredient-containing adhesive composition and laminating on the backing layer. The laminate produced in this way andl consisting of backing layer, layer supersaturated with active ingredient and removable protecting layer is then wound up, and the broad roll obtained in this way is cut into narrow rolls. It is true that pressure is briefly exe:rted on the active ingredient-containing layer on carrying out these process steps. However, as a consequence of the short operating time, this operation of pressure has no adverse effect on the crystallization behaviour of the active ingredient in the active ingredient-supersaturated layer. During the subsequent production process, individual plasters are cut out of the narrow rolls described above. For this i.t is necessary for the laminate to be unwound from the narrow rolls and transported by traction through the machine.
This entails use of so-called advance tractions. They grip the laminate from the side and transport it through the machine. During this it is unavoidable that pressure is exerted for a relatively long time on the layer supersaturated in active ingredient, resulting in initiation of crystallization of the active ingredient.
The invention is based on the objiect of indicating a process for the production, transport and storage of a transdermal therapeutic system in the form of a plaster, by which crystallization of the active ingredient is suppressed.
The object is achieved in a proceass of the type specified in the precharacterizing clause of Claim 1 with the invention by carrying it out avoiding process parameters which favour or induce crystalli~:ation of active ingredient, and avoiding any type of pressure operating on the plaster and, in particular, on the active layer while it is carried out.
Surprisingly, it has emerged that: crystallization of the active ingredient in the layer supersaturated with active ingredient can be suppressed by avoiding any type of prolonged operation of pressure on the plaster, and, in particular, on the active layer v~hile carrying out the process for the production, tran:cport and storage of a therapeutic system in the form oi: a plaster. This can be achieved by using reduced pressure to grip the plaster or parts thereof during transport procedures between operational steps in production or packaging. Gripping the plaster or parts thereof with thEa aid of suction devices avoids any operation of pressure during this. Another possibility for avoiding the operation of pressure is made possible according to the invention on use of gripping or holding devices during or between operational steps for the production, packaging or transport by them taking hold in each case at a distance from t:he contour of a plaster or of the active layer, for example in the area between separate individual plasters.
Finally, the operation of pressure on the finished plaster during packaging and dispatch to the final distributor is prevented by packaging finished plasters singly in a dimensionally stable pack which has at least limited pressure resistance.
The process according to the invention for the production of transdermal therapeutic systems in the form of plasters of the invention is advantageous:Ly and preferably employed for those groups of active ingredients prone to recrystallization in supersaturai:ed phase.
This entails use of so-called advance tractions. They grip the laminate from the side and transport it through the machine. During this it is unavoidable that pressure is exerted for a relatively long time on the layer supersaturated in active ingredient, resulting in initiation of crystallization of the active ingredient.
The invention is based on the objiect of indicating a process for the production, transport and storage of a transdermal therapeutic system in the form of a plaster, by which crystallization of the active ingredient is suppressed.
The object is achieved in a proceass of the type specified in the precharacterizing clause of Claim 1 with the invention by carrying it out avoiding process parameters which favour or induce crystalli~:ation of active ingredient, and avoiding any type of pressure operating on the plaster and, in particular, on the active layer while it is carried out.
Surprisingly, it has emerged that: crystallization of the active ingredient in the layer supersaturated with active ingredient can be suppressed by avoiding any type of prolonged operation of pressure on the plaster, and, in particular, on the active layer v~hile carrying out the process for the production, tran:cport and storage of a therapeutic system in the form oi: a plaster. This can be achieved by using reduced pressure to grip the plaster or parts thereof during transport procedures between operational steps in production or packaging. Gripping the plaster or parts thereof with thEa aid of suction devices avoids any operation of pressure during this. Another possibility for avoiding the operation of pressure is made possible according to the invention on use of gripping or holding devices during or between operational steps for the production, packaging or transport by them taking hold in each case at a distance from t:he contour of a plaster or of the active layer, for example in the area between separate individual plasters.
Finally, the operation of pressure on the finished plaster during packaging and dispatch to the final distributor is prevented by packaging finished plasters singly in a dimensionally stable pack which has at least limited pressure resistance.
The process according to the invention for the production of transdermal therapeutic systems in the form of plasters of the invention is advantageous:Ly and preferably employed for those groups of active ingredients prone to recrystallization in supersaturai:ed phase.
These include active ingredients selected from groups which comprise:
oc-adrenoceptor agonists such as, for example, xylometazoline, adrenolone, clon:i.dine, ephedrine, tiamenidine, ~3-adrenoceptor agonists such as, for example, formoterol, terbuterol, ritodrine, oc-adrenoceptor blockers such as, for example, dapiperazole, doxazosin, prazosin, yohimbine, trimazosin (3-adrenoceptor blockers such as, for example, acebutolol, atenolol, bisoprolol, bopindolol, bupranolol, propanolol, metoprolol, nadolol, pindolol, t;imolol, anabolics such as, for example, ~androstenediol, bolandiol, clostebol, 4-hydroxy-19-nortesto;sterone, methenolone, analgesics (narcotics) such as, .for example, alfentanil, buprenorphine, codeine, dimenoxadol, fentanyl, isomethadone, lofentanil, methadone, morphine, morphine derivatives, normethadone, normo;rphine, propiram, sufentanil, tilidine, analgesics (non-narcotics) such ;as, for example, aminopyrine, antipyrine, aspirin, benoxaprofen, bucetin, clometacin, etodolac, felbinac, fenoprofen, flubiprofen, ibufenac, indomethacin, indoprof~en, ketoprofen, keterolac, miroprofen, androgens such as, for example, :boldenone, fluoxymesterone, mestanolone, mesterolone, methandrostenolone, 17-methyltestosterone, l7oc-methyl-testosterone-3-cyclopentyl enol ether, norethandrolone, normethandrone, oxandrolone, oxymetholone, prasterone, stanolone, stanozolol, testosterone, testosterone 17-chloral hemiacetal, testosterone 17(3-cypionate, testosterone enanthate, testosterone nicotinate, testosterone phenylacetate, testosterone propionate, tiomesterone, anaesthetics such as, for example, amucaine, amylocaine, biphenamine, cocaine, diperodon, ecgonidine, euprocin, fenalcomine, fomocaine, hexobarbital, hexylcaine, hydroxydione, hydroxyprocaine, hydroxytetracaine, ketamine, leucinocaine mesylate, levoxadrol, lidocaine, mepivacaine, meprylcaine, metabutoxycaine, methohexital, m;idazolam, naepaine, octacaine, orthocaine, oxethazaine, parethoxycaine, phenacaine, piperocaine, polidocanol, pramoxine, prilocaine, procaine, propanocaine, propofol, risocaine, tetracaine, thialbarbital, thiam:Ylal, thiobutabarbital, thiopental, tolycaine, trimecain~s, zolamine, antiallergics such as, for example, amlexanox, astemizole, azelastine, cromolyn, fenpiprane,, histamine, repirinast, tiaramide, tranilast, traxanox, urushiol, ketotifen, nedocromil, oxatomide, pentigetide antiandrogens such as, for examp:Le, bifluranol, Cyoctol, cyproterone, oxendrolone, antianginals such as, for example, amlodipine, amyl nitrite, cinepazet maleate, imol~~nine, isosorbide dinitrate, limaprost, molsidomin~s, nitroxyalkylamide derivatives, antiarrhythmics such as, for example, acecainide, adenosine, ajmaline, alprenolol, amoproxan, aprindine, bretylium, tosylate, bubumolol, bunaftine, butidrine, butobendine, meobentine, mexiletine, moricizine, pirmenol, pronethalol, propafenone, pyrino7Line, penicillins such as, for example,, amdinocillin, pivoxil, amoxicillin, ampicillin, apa1ci17Lin, aspoxicillin, azidocillin, azlocillin, bacampic:illin, benzylpenicillin, carbenicillin, carfecillin, carindacillin, clometocillin, cloxacillin, cyclacillin, dicloxacillin, diphenicillin, epicillin, fenbenicillin, floxicillin, hetacillin, lenampicillin, metampicillin, mei:hicillin, mezlocillin, nafcillin, oxacillin, penamecillin, penethamate hydriodide, penicillin G benethamine, penicillin G
benzathine, penicillin G benzyhydrylamine, penicillin G
calcium, penicillin G hydrabamines, penicillin N, penicillin O, penicillin V, penicillin V benzathine, penicillin v hydrabamine, penimepicyclin, phenethicillin, piperacillin, pivapicillin, propicillin, quinacillin, sulbenicillin, talampicillin, temocillin, tiacarcillin, antidiabetics such as, for example, sulphonylurea derivatives, acetohexamide, carbutamide, chlorpropamide, glibornuride, gliclazide, glimep:iride, glipizide, gliquidone, glisoxepide, glyburide, glybuthiazole, glybuzole, glyhexamide, glymidine, glypinamide, phenbutamide, tolazamide, tolbutamide, tolcyclamide, acarbose, benzylthiazolidine-2,4~-dione, calcium mesoxalate, miglitol, antihistaminics such as, for example, acrivastine, bamipine, brompheniramine, chlorpheniramine, dimethindene, matron S, pheniramine, pyrrobutamine, thenaldine, tolpropamine, triprolidine, bietanautine, -bromodiphenhydramine, carbinoxamine, clemastine, diphenylpraline, doxylamine, embramine, medrylamine, mephenhydramine, p-methyldiphenhydramine, orphenadrine, phenyltoloxamine, piprinhydrinate, setastine, alloclamide, chloropyramine, chlorothen, histapyrrodine, methafurylene, methaphenilene, methapyrilene, phenbenzamine, pyrilamine, talastine, thenyldiamine, thonzy7lamine, tripelennamine, zolamine, cetirizine, chlorcyclizine, clocinizine, hydroxyzine, tricyclics, antimigraine agents, hydrogenated ergot alkaloids, ~i-adrenoreceptor blockers, Ca channel blockers, serotonin antagonists, platelet aggregation inhibitors, antidepressants such as, for example, alpiropride, dihydroergotamine, ergocornine, esrcocorninine, ergocryptine, ergot, ergotamine, flumedroxone acetate, fonazine, methysergide, oxetorone, pizotyline, sumatriptan, anagrelide, argatroban, cilostazol, daltroban, defibrotide, enoxapar:in, Fraxiparin~, indobufen, lamoparan, ozagrel, p:icotamide, plafibride, tedelparin, ticlopidine, triflusal, bronchodilators such as, for exa~aple, ephedrine derivatives such as, for example,, albuterol, bambuterol, bitolterol, carbuterol, clenbute:rol, chlorprenaline, dioxethedrine, eprozinol, etafed:rine, ethylnorepinephrine, fenoterol, hexoprenaline, isoetharine, isoproterenol, mabuterol, metaproterenol, N-metlaylephedrine, pirbuterol, procaterol, protokylol, reproterol, rimiterol, soterenol, terbutaline, tulobuterol, oestrogens such as, for example, benzestrol, broparoestrol, chlorotrianisene, dienestrol, diethylstilbestrol, diethylstilb~astrol dipropionate, dimestrol, fosfestrol, hexestrol, methallenestril, -g-methestrol, colpormon, equilenin,, eguilin, conjugated oestrogenic hormones, oestrogen esters, estropipate, 17(3-estradiol, estradiol, estradiol benzoate, estradiol 17~3-cypionate, estriol, estrone, ethinyl estradiol, mestranol, moxestrol, mytatrienediol, polyestradiol phosphate, quinestradiol, quinestrol, gestagens such as, for example, allylestrenol, anagestone, chlormadinone acetate, delmadinone acetate, demegestone, desogestrel, dimethisterone, dydrogesterone, ethinylestrenol, ethisterone, ethynodiol, ethynodiol diacetate, flurogestone acetate, gestodene, gestonorone caproate, haloprogesterone, 17-hydroxy-16-methyleneprogesterone, l7oc-hydroxyprogesterone, 17a-hydroxygesterone caproate, levonorgestrel, lynestrenol, medrogestone, medroxyprogesterone, megestrol acetate, melengestrol, norethindrone, nore3thindrone acetate, norethynodrel, norgesterone, norc~estimate, norgestrel, norgestrienone, 19-norprogesterone, norvinisterone, pentagestrone, progesterone, pro=negestone, quirigestrone, trengestone, vasodilators such as, for example, bencyclane, ciclonicate, cinnarizine, citico:Line, diisopropylamine dichloroacetate, eburnamonine, fe3noxedil, ibudilast, ifenprodil, nafronyl, nicametate" nicergoline, ninodipine, papaverine, pentifylline, tinofedrine, vincamine, vinpocetine, amotriphene, bendazol, benfurodil hemisuccinate, benziodarone, chloracyzine, chromonar, clobenfurol, clonitrate, dilazep" dipyridamole, dropenilamine, efloxate, erythrii~ol, erythrityl tetranitrate, etafenone, floredi:L, ganglefene, hexestrol bis((3-diethylaminoethyl ether), lzexobendine, isosorbide dinitrate, itramin tosylate, khe:Llin, lidoflazine, mannitol hexanitrate, medibazine,, nicorandil, _g_ pentaerythritol tetranitrate, pentrinitrol, pimefylline, prenylamine, propatyl nitrate, pyridofylline, trapidil, tricromyl, trimetazidine, trolnitrate phosphate, visnadine, bamethan, betahistine, bradykinin, brovincamine, bufeniode, buflomedil, butalamine, cetiedil, ciclonicate, cinepazide, cyclandelate, eledoisin, hepronicate, inositol niacinate, isoxsuprine, kallidin, kallikrein, moxisylyte, nicofura;nose, nylidrin, piribedil, suloctidil, xanthinal and aiacinate.
oc-adrenoceptor agonists such as, for example, xylometazoline, adrenolone, clon:i.dine, ephedrine, tiamenidine, ~3-adrenoceptor agonists such as, for example, formoterol, terbuterol, ritodrine, oc-adrenoceptor blockers such as, for example, dapiperazole, doxazosin, prazosin, yohimbine, trimazosin (3-adrenoceptor blockers such as, for example, acebutolol, atenolol, bisoprolol, bopindolol, bupranolol, propanolol, metoprolol, nadolol, pindolol, t;imolol, anabolics such as, for example, ~androstenediol, bolandiol, clostebol, 4-hydroxy-19-nortesto;sterone, methenolone, analgesics (narcotics) such as, .for example, alfentanil, buprenorphine, codeine, dimenoxadol, fentanyl, isomethadone, lofentanil, methadone, morphine, morphine derivatives, normethadone, normo;rphine, propiram, sufentanil, tilidine, analgesics (non-narcotics) such ;as, for example, aminopyrine, antipyrine, aspirin, benoxaprofen, bucetin, clometacin, etodolac, felbinac, fenoprofen, flubiprofen, ibufenac, indomethacin, indoprof~en, ketoprofen, keterolac, miroprofen, androgens such as, for example, :boldenone, fluoxymesterone, mestanolone, mesterolone, methandrostenolone, 17-methyltestosterone, l7oc-methyl-testosterone-3-cyclopentyl enol ether, norethandrolone, normethandrone, oxandrolone, oxymetholone, prasterone, stanolone, stanozolol, testosterone, testosterone 17-chloral hemiacetal, testosterone 17(3-cypionate, testosterone enanthate, testosterone nicotinate, testosterone phenylacetate, testosterone propionate, tiomesterone, anaesthetics such as, for example, amucaine, amylocaine, biphenamine, cocaine, diperodon, ecgonidine, euprocin, fenalcomine, fomocaine, hexobarbital, hexylcaine, hydroxydione, hydroxyprocaine, hydroxytetracaine, ketamine, leucinocaine mesylate, levoxadrol, lidocaine, mepivacaine, meprylcaine, metabutoxycaine, methohexital, m;idazolam, naepaine, octacaine, orthocaine, oxethazaine, parethoxycaine, phenacaine, piperocaine, polidocanol, pramoxine, prilocaine, procaine, propanocaine, propofol, risocaine, tetracaine, thialbarbital, thiam:Ylal, thiobutabarbital, thiopental, tolycaine, trimecain~s, zolamine, antiallergics such as, for example, amlexanox, astemizole, azelastine, cromolyn, fenpiprane,, histamine, repirinast, tiaramide, tranilast, traxanox, urushiol, ketotifen, nedocromil, oxatomide, pentigetide antiandrogens such as, for examp:Le, bifluranol, Cyoctol, cyproterone, oxendrolone, antianginals such as, for example, amlodipine, amyl nitrite, cinepazet maleate, imol~~nine, isosorbide dinitrate, limaprost, molsidomin~s, nitroxyalkylamide derivatives, antiarrhythmics such as, for example, acecainide, adenosine, ajmaline, alprenolol, amoproxan, aprindine, bretylium, tosylate, bubumolol, bunaftine, butidrine, butobendine, meobentine, mexiletine, moricizine, pirmenol, pronethalol, propafenone, pyrino7Line, penicillins such as, for example,, amdinocillin, pivoxil, amoxicillin, ampicillin, apa1ci17Lin, aspoxicillin, azidocillin, azlocillin, bacampic:illin, benzylpenicillin, carbenicillin, carfecillin, carindacillin, clometocillin, cloxacillin, cyclacillin, dicloxacillin, diphenicillin, epicillin, fenbenicillin, floxicillin, hetacillin, lenampicillin, metampicillin, mei:hicillin, mezlocillin, nafcillin, oxacillin, penamecillin, penethamate hydriodide, penicillin G benethamine, penicillin G
benzathine, penicillin G benzyhydrylamine, penicillin G
calcium, penicillin G hydrabamines, penicillin N, penicillin O, penicillin V, penicillin V benzathine, penicillin v hydrabamine, penimepicyclin, phenethicillin, piperacillin, pivapicillin, propicillin, quinacillin, sulbenicillin, talampicillin, temocillin, tiacarcillin, antidiabetics such as, for example, sulphonylurea derivatives, acetohexamide, carbutamide, chlorpropamide, glibornuride, gliclazide, glimep:iride, glipizide, gliquidone, glisoxepide, glyburide, glybuthiazole, glybuzole, glyhexamide, glymidine, glypinamide, phenbutamide, tolazamide, tolbutamide, tolcyclamide, acarbose, benzylthiazolidine-2,4~-dione, calcium mesoxalate, miglitol, antihistaminics such as, for example, acrivastine, bamipine, brompheniramine, chlorpheniramine, dimethindene, matron S, pheniramine, pyrrobutamine, thenaldine, tolpropamine, triprolidine, bietanautine, -bromodiphenhydramine, carbinoxamine, clemastine, diphenylpraline, doxylamine, embramine, medrylamine, mephenhydramine, p-methyldiphenhydramine, orphenadrine, phenyltoloxamine, piprinhydrinate, setastine, alloclamide, chloropyramine, chlorothen, histapyrrodine, methafurylene, methaphenilene, methapyrilene, phenbenzamine, pyrilamine, talastine, thenyldiamine, thonzy7lamine, tripelennamine, zolamine, cetirizine, chlorcyclizine, clocinizine, hydroxyzine, tricyclics, antimigraine agents, hydrogenated ergot alkaloids, ~i-adrenoreceptor blockers, Ca channel blockers, serotonin antagonists, platelet aggregation inhibitors, antidepressants such as, for example, alpiropride, dihydroergotamine, ergocornine, esrcocorninine, ergocryptine, ergot, ergotamine, flumedroxone acetate, fonazine, methysergide, oxetorone, pizotyline, sumatriptan, anagrelide, argatroban, cilostazol, daltroban, defibrotide, enoxapar:in, Fraxiparin~, indobufen, lamoparan, ozagrel, p:icotamide, plafibride, tedelparin, ticlopidine, triflusal, bronchodilators such as, for exa~aple, ephedrine derivatives such as, for example,, albuterol, bambuterol, bitolterol, carbuterol, clenbute:rol, chlorprenaline, dioxethedrine, eprozinol, etafed:rine, ethylnorepinephrine, fenoterol, hexoprenaline, isoetharine, isoproterenol, mabuterol, metaproterenol, N-metlaylephedrine, pirbuterol, procaterol, protokylol, reproterol, rimiterol, soterenol, terbutaline, tulobuterol, oestrogens such as, for example, benzestrol, broparoestrol, chlorotrianisene, dienestrol, diethylstilbestrol, diethylstilb~astrol dipropionate, dimestrol, fosfestrol, hexestrol, methallenestril, -g-methestrol, colpormon, equilenin,, eguilin, conjugated oestrogenic hormones, oestrogen esters, estropipate, 17(3-estradiol, estradiol, estradiol benzoate, estradiol 17~3-cypionate, estriol, estrone, ethinyl estradiol, mestranol, moxestrol, mytatrienediol, polyestradiol phosphate, quinestradiol, quinestrol, gestagens such as, for example, allylestrenol, anagestone, chlormadinone acetate, delmadinone acetate, demegestone, desogestrel, dimethisterone, dydrogesterone, ethinylestrenol, ethisterone, ethynodiol, ethynodiol diacetate, flurogestone acetate, gestodene, gestonorone caproate, haloprogesterone, 17-hydroxy-16-methyleneprogesterone, l7oc-hydroxyprogesterone, 17a-hydroxygesterone caproate, levonorgestrel, lynestrenol, medrogestone, medroxyprogesterone, megestrol acetate, melengestrol, norethindrone, nore3thindrone acetate, norethynodrel, norgesterone, norc~estimate, norgestrel, norgestrienone, 19-norprogesterone, norvinisterone, pentagestrone, progesterone, pro=negestone, quirigestrone, trengestone, vasodilators such as, for example, bencyclane, ciclonicate, cinnarizine, citico:Line, diisopropylamine dichloroacetate, eburnamonine, fe3noxedil, ibudilast, ifenprodil, nafronyl, nicametate" nicergoline, ninodipine, papaverine, pentifylline, tinofedrine, vincamine, vinpocetine, amotriphene, bendazol, benfurodil hemisuccinate, benziodarone, chloracyzine, chromonar, clobenfurol, clonitrate, dilazep" dipyridamole, dropenilamine, efloxate, erythrii~ol, erythrityl tetranitrate, etafenone, floredi:L, ganglefene, hexestrol bis((3-diethylaminoethyl ether), lzexobendine, isosorbide dinitrate, itramin tosylate, khe:Llin, lidoflazine, mannitol hexanitrate, medibazine,, nicorandil, _g_ pentaerythritol tetranitrate, pentrinitrol, pimefylline, prenylamine, propatyl nitrate, pyridofylline, trapidil, tricromyl, trimetazidine, trolnitrate phosphate, visnadine, bamethan, betahistine, bradykinin, brovincamine, bufeniode, buflomedil, butalamine, cetiedil, ciclonicate, cinepazide, cyclandelate, eledoisin, hepronicate, inositol niacinate, isoxsuprine, kallidin, kallikrein, moxisylyte, nicofura;nose, nylidrin, piribedil, suloctidil, xanthinal and aiacinate.
Claims (6)
1. Process for avoiding crystallization of active ingredient from the active layer, which is supersaturated with active ingredient, of a therapeutic system which is in the form of a therapeutic plaster, during the stages of production or preparation, transport and storage, characterized in that during said stages, any kind of pressure operating on the plaster and, in particular, on the active layer is avoided.
2. Process according to claim 1, characterized in that the transfer of the plaster or of parts thereof is carried out between operational steps in production or packaging by means of sucking action or reduced pressure.
3. Process according to claim 1 or 2, characterized in that during or between operational steps for production, packaging or transport, gripping or holding devices take hold in each case at a distance from the contour of a plaster or the active layer.
4. Process according to claim 3, characterized in that the said devices take hold in the area between the separated individual plasters.
5. Process according to any one of claims 1 to 4, characterized in that finished plasters are packed singly in a dimensionally stable pack with at least limited pressure resistance.
6. Therapeutic systems in the form of plasters having an active layer supersaturated with active ingredient, characterized by a dimensionally stable pack protecting the plaster, in particular the layer which is supersaturated with active ingredient, from the action of pressure.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19649535.0 | 1996-11-29 | ||
| DE19649535A DE19649535C2 (en) | 1996-11-29 | 1996-11-29 | Process for the production of a plaster-shaped therapeutic system |
| PCT/EP1997/005608 WO1998023266A1 (en) | 1996-11-29 | 1997-10-10 | Method for producing a therapeutic system in the form of plaster |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2272437A1 true CA2272437A1 (en) | 1998-06-04 |
Family
ID=7813150
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002272437A Abandoned CA2272437A1 (en) | 1996-11-29 | 1997-10-10 | Method for producing a therapeutic system in the form of plaster |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US6254558B1 (en) |
| EP (1) | EP0941077A1 (en) |
| JP (1) | JP2001508045A (en) |
| KR (1) | KR20000057306A (en) |
| AU (1) | AU726962B2 (en) |
| CA (1) | CA2272437A1 (en) |
| DE (1) | DE19649535C2 (en) |
| NO (1) | NO992409D0 (en) |
| WO (1) | WO1998023266A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE60326017D1 (en) * | 2003-08-28 | 2009-03-12 | Purimed Co Ltd | EXTRACT FROM NELUMBINIS SEED FOR THE TREATMENT OF DEPRESSION |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61293911A (en) * | 1985-06-24 | 1986-12-24 | Teisan Seiyaku Kk | Sustained release preparation |
| JP3002492B2 (en) * | 1990-03-12 | 2000-01-24 | 積水化学工業株式会社 | Transdermal formulation |
| GB9021674D0 (en) * | 1990-10-05 | 1990-11-21 | Ethical Pharma Ltd | Transdermal device |
| JPH04261119A (en) * | 1991-02-13 | 1992-09-17 | Lintec Corp | Percutaneous absorption-type pharmaceutical preparation |
| DE4210711A1 (en) * | 1991-10-31 | 1993-05-06 | Schering Ag Berlin Und Bergkamen, 1000 Berlin, De | TRANSDERMAL THERAPEUTIC SYSTEMS WITH CRYSTALIZATION INHIBITORS |
-
1996
- 1996-11-29 DE DE19649535A patent/DE19649535C2/en not_active Expired - Fee Related
-
1997
- 1997-10-10 EP EP97912168A patent/EP0941077A1/en not_active Withdrawn
- 1997-10-10 KR KR1019990704737A patent/KR20000057306A/en not_active Application Discontinuation
- 1997-10-10 US US09/308,968 patent/US6254558B1/en not_active Expired - Fee Related
- 1997-10-10 WO PCT/EP1997/005608 patent/WO1998023266A1/en not_active Application Discontinuation
- 1997-10-10 AU AU49469/97A patent/AU726962B2/en not_active Ceased
- 1997-10-10 JP JP52417998A patent/JP2001508045A/en active Pending
- 1997-10-10 CA CA002272437A patent/CA2272437A1/en not_active Abandoned
-
1999
- 1999-05-20 NO NO992409A patent/NO992409D0/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| EP0941077A1 (en) | 1999-09-15 |
| NO992409L (en) | 1999-05-20 |
| AU726962B2 (en) | 2000-11-30 |
| NO992409D0 (en) | 1999-05-20 |
| DE19649535A1 (en) | 1998-06-04 |
| WO1998023266A1 (en) | 1998-06-04 |
| DE19649535C2 (en) | 2000-02-10 |
| AU4946997A (en) | 1998-06-22 |
| KR20000057306A (en) | 2000-09-15 |
| US6254558B1 (en) | 2001-07-03 |
| JP2001508045A (en) | 2001-06-19 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued | ||
| FZDE | Discontinued |
Effective date: 20031010 |